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Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

Deliverables

DSS stakeholder interaction workshop

We will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.

Two workshops with strong participation from regulators

Two workshops will be organised with at least 15 external participants each, from regulatory bodies and expert-level scientific committees related to regulatory bodies, plus additional high-level participants from research and development.

Reflection Document

A reflection document will present the outline of the methodology to design intelligent testing strategies, considerations regarding populating the repository and ranking methods according to product and measurand, current observations on CQAs, as well as approaches and structures intended for the DSS. This document will serve both as an internal orientation and as a foundation for interaction with external stakeholders as it will feed into the whitepaper-drafting in WP1.

First draft of whitepaper

The draft whitepaper will propose a catalogue of information requirements and needs for harmonisation (e.g. to address borderline products that fall under different legislature in different world regions). It will propose a gap analysis, where scientific state of the art and regulatory practice seem out of step (e.g. present a list of major adversities of administered NBMs described in the scientific literature, that are hard to predict by current standard testing methods). Thirdly the document will propose a heuristic how to assimilate new evidence in reliable and efficient way into regulatory strategies (e.g. which testing methods would deliver information that supports the modeling of an NMB-specific Adverse Outcome Pathway, for example for CARPA ).

Report on in vitro characterization of nanoparticle distribution

Report on the quantitative evaluation of key variables such as apparent permeability through various barriers systems, or uptake kinetics in key cell populations

First beta version DSS

We will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.

Knowledge-HUB (K-HUB: Social media strategy implementation, explicit knowledge sharing repository)

This online platform should provide access to all non-confidential REFINE results. The platform should be searchable and allow filtering, contributions and -if deemed useful- opportunities to engage in online discussions. We will make use of the glossary of terminology to appeal to various stakeholder communities.

Searching for OpenAIRE data...

Publications

Organoid Formation Driven by Synthetic Biomaterials Mimicking the Basement Membrane

Author(s): Valeria Perugini, Matteo Santin
Published in: Chinese-European Societies for Biomaterials Conference, 2019

Perivascular Niche Based on Hyperbranched Laminin Dendron as a New Feasible Approach to Ameliorate Stemness Deprivation During In Vitro Expansion

Author(s): Valeria Perugini, Matteo Santin
Published in: 30th European Society for Biomaterials Conference, 2019, Page(s) III-OS10-05 page 188

Synthetic Basement Membrane Analogues Induce the formation of 3D Tissue-like Structures in 2D Cultures

Author(s): Matteo Santin (Invited Keynote Speaker)
Published in: Tissue Engineering and Regenerative Medicine International Societies (TERMIS) 2019, 2019, Page(s) 726

Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products

Author(s): B. HALAMODA-KENZAOUI, H. BOX, M. VAN ELK, S. GAITAN, R. GEERTSMA, E. GAINZA LAFUENTE, A. OWEN, A. DEL POZO, M. ROESSLEIN, S. BREMER- HOFFMANN
Published in: Precision Nanomedicine, 2020, ISSN 2639-9431
DOI: 10.33218/001c.13521

Nanomedicinal products: An integrated approach for immunotoxicity testing

Author(s): Christina Giannakou
Published in: 2019

Anticipation of regulatory needs for nanotechnology-enabled health products

Author(s): B. HALAMODA-KENZAOUI, H. BOX, M. VAN ELK, S. GAITAN, R. GEERTSMA, E. GAINZA LAFUENTE, A. OWEN, A. DEL POZO, M. ROESSLEIN, S. BREMER- HOFFMANN
Published in: 2019, ISSN 1831-9424
DOI: 10.2760/596822